NCT01591850

Brief Summary

This randomized, single-center, open-label, one-sequence, two-period crossover study in three parts will assess the effects of multiple doses of ketoconazole, rifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy male and female volunteers. In Period 1, subjects will receive a single oral dose of RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated time on study is up to 8.5 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

May 3, 2012

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

  • Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

    Pre-dose and up to 72 hours post-dose

  • Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

    Pre-dose and up to 72 hours post-dose

  • Part 3: Effect of multiple doses of ritonavir-boosted atazanavir on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

    Pre-dose and up to 72 hours post-dose

Secondary Outcomes (3)

  • Safety: Incidence of adverse events

    approximately 6 month

  • RO5093151 metabolites: Plasma/urine concentrations

    Pre-dose and up to 72 hours post-dose

  • Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only)

    Pre-dose and up to 24 hours post-dose

Study Arms (3)

1 Ketoconazole DDI

EXPERIMENTAL
Drug: RO5093151Drug: ketoconazole

2 Rifampicin DDI

EXPERIMENTAL
Drug: RO5093151Drug: rifampicin

3 ATZ/r DDI

EXPERIMENTAL
Drug: RO5093151Drug: atazanavirDrug: ritonavir

Interventions

RO5093151DRUG

Single oral dose

1 Ketoconazole DDI2 Rifampicin DDI3 ATZ/r DDI
atazanavirDRUG

Multiple oral doses

3 ATZ/r DDI
ketoconazoleDRUG

Multiple oral doses

1 Ketoconazole DDI
rifampicinDRUG

Multiple oral doses

2 Rifampicin DDI
ritonavirDRUG

Multiple oral doses

3 ATZ/r DDI

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female subjects, 18 to 65 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination
  • Body mass index (BMI) 18 to 30 kg/m2
  • Females of child-bearing potential must agree to use two effective methods of contraception, including a barrier method and an intrauterine non-hormonal device (set in place at least 3 months before first dosing) for the duration of the study and at least 1 month after last dosing
  • Non-smoker for at least 90 days prior to screening

You may not qualify if:

  • Pregnant or lactating females
  • History of drug abuse in the past 2 years, or suspicion of regular consumption of drugs of abuse, or positive result on drugs of abuse test
  • History of alcoholism in the past 2 years, or positive alcohol test
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Systemic , topical, intranasal or inhaled corticosteroid therapy for more than 2 weeks within 3 months prior to screening
  • Participation in an investigational drug or device study within 90 days prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merritt Island, Florida, 32953, United States

Location

MeSH Terms

Interventions

Atazanavir SulfateKetoconazoleRifampinRitonavir

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsPiperazinesRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 4, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)